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According to the initial report received for journal article: ¿do renal tumor characteristics affect the number of hemostatic agents used during partial nephrectomy?¿ retrospective study of 71 patients who undergone partial nephrectomy (pn) surgery due to renal mass between january 2013 and february 2019.Each patient was administered one or more hemostatic agent (ha) during the procedure.Article mentions postoperative complications of urinary leakage, arteriovenous fistula, embolization, urinary tract infection.However they do not state whether these complications occurred to those 17 patients that bioglue was applied to.
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In the journal article ¿do renal tumor characteristics affect the number of hemostatic agents used during partial nephrectomy?¿ a retrospective study of 71 patients who had undergone partial nephrectomy (pn) surgery due to renal mass between january 2013 and february 2019.Each patient was administered one or more hemostatic agents (ha) during the procedure.Hemostasis of excision bed achieved using absorbable sutures.Excision cavity was filled with a hemostatic agent or autologous perirenal fat based on surgeon¿s choice and cavity size.Clips were used in laparoscopic partial nephrectomy (lpn) procedures.Polytetrafluoroethylene (ptfe) pledgets were used to prevent tearing of parenchyma.If needed and based on surgeon¿s choice, either another manufacturer's adhesive or bioglue (n=17, 23.9%) alone or combined were used on renography area.The article mentions postoperative complications of urinary leakage (n=2), arteriovenous fistula/embolization (n=1), urinary tract infection (n=1).However they do not state whether these complications occurred to those 17 patients that bioglue was used on.The following is unknown: how much bioglue was used during each procedure, how many cases included the use of bioglue only, how many cases included the combined use of another manufacturer's adhesive and bioglue, and how many bioglue patients had reported complications.There is insufficient information to determine if there is an association between the use of bioglue and the reported complications.The article does not specify what hemostatic agents caused the adverse events, or whether the complications are associated with the use of bioglue.Urinary leakage: hidas et al (2006) performed a study of 174 patients undergoing nss operations for renal cell carcinoma.31 patients used bioglue only for sealing, while 143 patients underwent the traditional suturing technique.There were no patients in the bioglue group that suffered urinary leaks, 3 patients in the traditional suture group did have urinary leakage.They found that bioglue ¿significantly decreased the blood loss and transfusion rate, as well as the renal ischemic and operative times, without increasing the risk of urinary leakage.¿ bahouth et al (2017) retrospectively analyzed 507 patients with 255 patients undergoing tumor bed closure with bioglue.They concluded that closing the tumor bed with bioglue is feasible and safe.Arteriovenous fistula/embolization: embolization of bioglue has been reported previously in literature (bernabeu 2005, furukawa 2015).However, guidance related to the prevention of bioglue embolism is provided in the instructions for use.Warning in the ifu states, ¿do not allow bioglue in either the uncured or polymerized form to contact circulation blood.Bioglue entering the circulation can result in local or vascular obstruction.¿ vessel obstruction is also listed in the ifu as a potential adverse event.Arteriovenous fistula is an abnormal connection between an artery and a vein.These connections may form as a result of inflammation or altered anatomy secondary to surgical procedures.It is unlikely that bioglue would play a role in the development of an arteriovenous fistula.Urinary tract infection: there is no literature to date reporting urinary tract infections being associated with or being caused by bioglue.Bioglue undergoes a validated terminal sterilization process; it is unlikely the infection is related to the product.There is insufficient information to determine if there is an association between the use of bioglue and the reported complications.The article does not state which hemostatic agent(s) caused which complication, and does not specifically associate bioglue with any of the reported adverse events.No further action required.Risk analysis of the reported event has determined the complications listed in the event are adequately addressed in the risk file.Based on the information available at the time of this report, an exact root cause of the events observed in the patients cannot be conclusively determined.Bioglue undergoes a validated terminal sterilization process; it is unlikely the complications are related to the product.There is insufficient information to determine if there is an associate between the use of bioglue and the reported complications.Further, the article does not state which hemostatic agent(s) caused which complication and does not specifically associate bioglue with any of the reported adverse events.No further action is required.Each individual hazard is mitigated and reduced as low as possible by design and process.Post-production residual risk is communicated in the product¿s labeling and ifu (instructions for use).This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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According to the initial report received for journal article: ¿do renal tumor characteristics affect the number of hemostatic agents used during partial nephrectomy?¿ retrospective study of 71 patients who undergone partial nephrectomy (pn) surgery due to renal mass between january 2013 and february 2019.Each patient was administered one or more hemostatic agent (ha) during the procedure.Article mentions postoperative complications of urinary leakage, arteriovenous fistula, embolization, urinary tract infection.However they do not state whether these complications occurred to those 17 patients that bioglue was applied to.
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